Advanced patient management for triaging health-related data using color codes

ABSTRACT

Systems, devices and methods for triaging health-related data, such as significant health-related events associated with health-related parameters, are disclosed. One aspect is a method for use in managing a patient&#39;s health within a patient management system. In various embodiments of the method, a number of predetermined events are accessed. The events are related to the patient&#39;s health and are identified by the patient management system. Each of the predetermined events are classified according to severity using a color-code system. In various embodiments, a red event is an imminent life threatening event, a yellow event is a serious health-related condition that is not imminently life threatening, and a green event is an event that is neither an imminent life threatening event nor a serious health-related condition. Other aspects and embodiments are provided herein.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is related to the following commonly assignedU.S. patent applications which are herein incorporated by reference intheir entirety: “Method and Apparatus for Establishing Context AmongEvents and Optimizing Implanted Medical Device Performance,” Ser. No.10/093,353, filed on Mar. 6, 2002 (Attorney Docket No. 279.364US1);“Advanced Patient Management For Acquiring, Trending and DisplayingHealth-Related Parameters,” Ser. No. ______, filed on ______ (AttorneyDocket No. 279.584US1); “Advanced Patient Management For Defining,Identifying and Using Predetermined Health-Related Events,” Ser. No.______, filed on ______ (Attorney Docket No. 279.585US1); “AdvancedPatient Management For Reporting Multiple Health-Related Parameters,”Ser. No. ______, filed on ______ (Attorney Docket No. 279.586US1);“Advanced Patient Management System With Environmental Data,” Ser. No.______, filed on ______ (Attorney Docket No. 279.588US1); “AdvancedPatient Management For Identifying, Displaying And Assisting WithCorrelating Health-Related Data,” Ser. No. ______, filed on ______(Attorney Docket No. 279.589US1); “Advanced Patient Management WithComposite Parameter Indices,” Ser. No. ______, filed on ______ (AttorneyDocket No. 279.590US1); and “Advanced Patient Management For TriagingHealth-Related Data,” Ser. No. ______, filed on ______ (Attorney DocketNo. 279.591US1).

TECHNICAL FIELD

[0002] This application relates generally to medical devices and, moreparticularly, to advanced patient management through the triaging ofhealth-related parameters.

BACKGROUND

[0003] An Implantable Medical Device (IMD) is a medical device designedto be chronically implanted in a human or other organism. Some IMDsinclude sensors to monitor a patient's condition, and some IMDs havebeen used to treat a patient. Some examples of IMDs include implantablecardiac rhythm management (CRM) devices such as cardiac pacemakers andimplantable cardioverter/defibrillators (ICDs). Other examples of IMDsinclude a number of monitors or sensors, stimulators and deliverysystems for both cardiac-related applications and non-cardiac-relatedapplications.

[0004] The sensed data from the IMD is capable of being wirelesslycommunicated to an external device, and the external device is capableof wirelessly programming the IMD. For example, data from an implantableCRM is capable of being wirelessly communicated to a programmer device.Additionally, the programmer is capable of wirelessly communicating withthe implantable CRM to program the CRM to perform a desired devicefunction.

[0005] Due to the potentially large amount of data capable of beingsensed by one or more IMDs, it is desired to appropriately process thelarge amount of sensed data to provide meaningful and timely informationto provide health-care information. The sensed data alone may not be anaccurate indication of the overall health of the patient because otherfactors can significantly influence the sensed data. Thus, it has beenproposed to use patient data from other sources. However, this patientdata can compound the problem of providing meaningful data, and stillmay not provide an accurate and timely indication of the overall healthof the patient.

SUMMARY

[0006] The above mentioned problems are addressed by the present subjectmatter and will be understood by reading and studying the followingspecification. One aspect is a method for use in managing a patient'shealth within a patient management system. In various embodiments of themethod, a number of predetermined events are accessed. The events arerelated to the patient's health and are identified by the patientmanagement system. Each of the predetermined events are classifiedaccording to severity using a color-code system. In various embodiments,a red event is an imminent life threatening event, a yellow event is aserious health-related condition that is not imminently lifethreatening, and a green event is an event that is neither an imminentlife threatening event nor a serious health-related condition.

[0007] These and other aspects, embodiments, advantages, and featureswill become apparent from the following description and the referenceddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]FIG. 1 illustrates an advanced patient management (APM) systemaccording to various embodiments of the present subject matter.

[0009]FIG. 2 illustrates an advanced patient management (APM) systemaccording to various embodiments of the present subject matter.

[0010]FIG. 3 illustrates an advanced patient management (APM) systemhaving direct communication links according to various embodiments ofthe present subject matter.

[0011]FIG. 4 illustrates an advanced patient management (APM) systemhaving network communication links according to various embodiments ofthe present subject matter.

[0012]FIG. 5 illustrates an advanced patient management (APM) systemhaving network communication links according to various embodiments ofthe present subject matter.

[0013]FIG. 6 illustrates a perspective view of an advanced patientmanagement (APM) system that includes an IMD and a portable device suchas a PDA.

[0014]FIG. 7 illustrates a perspective view of an advanced patientmanagement (APM) system that includes an IMD, a portable device such asa PDA, and another wellness monitoring device, such as a programmer forthe IMD, networked to the PDA.

[0015]FIG. 8 illustrates a perspective view of an advanced patientmanagement (APM) system that includes an IMD, a portable device such asa PDA, and another wellness monitoring device, such as a programmer forthe IMD, directly connected to the PDA.

[0016]FIG. 9 illustrates a block diagram of an IMD according to variousembodiments of the present subject matter.

[0017]FIG. 10 illustrates a block diagram of a wellness monitoringdevice, such as a portable device, according to various embodiments ofthe present subject matter.

[0018]FIG. 11 illustrates various embodiments of a wellness monitoringdevice (WMD) in the form of a general-purpose computing device.

[0019]FIG. 12 illustrates a block diagram of an advanced patientmanagement system for acquiring, trending and displaying multiplehealth-related parameters according to various embodiments of thepresent subject matter.

[0020]FIG. 13 illustrates a block diagram of a wellness trending displaygenerally illustrating parameter trends available for display accordingto various embodiments of the present subject matter.

[0021]FIG. 14 illustrates a block diagram of a wellness trending displayillustrating an arrangement for selecting and displaying parametertrends according to various embodiments of the present subject matter.

[0022]FIG. 15 illustrates an example of a wellness trending display.

[0023]FIG. 16 illustrates a block diagram according to various aspectsof the present subject matter in which a diagnostic context is providedto assist with interpreting the health condition of the patient, and toappropriately adjust the device and/or medical therapy, accordingly.

[0024]FIG. 17 illustrates a method for managing a patient's health bydefining, detecting and using predetermined health-related events,according to various embodiments of the present subject matter.

[0025]FIG. 18 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of detecting predeterminedhealth-related events, according to various embodiments of the presentsubject matter.

[0026]FIG. 19 illustrates a wellness monitoring device (WMD) formonitoring a patient's health condition that is capable of detectingpredetermined health-related events, according to various embodiments ofthe present subject matter.

[0027]FIG. 20 illustrates a method for reporting multiple parametersrelated to a health condition of a patient, according to variousembodiments of the present subject matter.

[0028]FIG. 21 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of prioritizingcommunication of health-related parameters, according to variousembodiments of the present subject matter.

[0029]FIG. 22 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of synthesizingenvironmental parameters with IMD parameters, according to variousembodiments of the present subject matter.

[0030]FIG. 23 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of correlating trendedparameters, predetermined events, and alerts, according to variousembodiments of the present subject matter.

[0031]FIG. 24 illustrates a method to generate composite parameters foruse in managing a patient's health, according to various embodiments ofthe present subject matter.

[0032]FIG. 25 illustrates a method to generate composite parameters foruse in managing a patient's health, according to various embodiments ofthe present subject matter.

[0033]FIG. 26 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of generating compositeparameters, according to various embodiments of the present invention.

[0034]FIG. 27 illustrates a method to triage predetermined events foruse in managing a patient's health, according to various embodiments ofthe present subject matter.

[0035]FIG. 28 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of classifying a number ofpredetermined events according to severity, and performing a systemaction based on the classification, according to various embodiments ofthe present subject matter.

DETAILED DESCRIPTION OF THE INVENTION

[0036] The following detailed description refers to the accompanyingdrawings which show, by way of illustration, specific aspects andembodiments in which the present subject matter may be practiced. Theseembodiments are described in sufficient detail to enable those skilledin the art to practice the present subject matter. Other embodiments maybe utilized and structural, logical, and electrical changes may be madewithout departing from the scope of the present subject matter. Thevarious embodiments disclosed herein are not necessarily mutuallyexclusive, as some disclosed embodiments can be combined with one ormore other disclosed embodiments to form new embodiments. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present subject matter is defined only by theappended claims, along with the full scope of equivalents to which suchclaims are entitled.

[0037] The present subject matter provides a system to assist withmonitoring the overall health of patients, and thus to assess and treathealth conditions, by triaging health-parameters. In variousembodiments, a clinician such as a physician monitors the patient'shealth. In various embodiments, the system includes an implantablemedical device (IMD) which is capable of sensing various health-relatedparameters (also referred to herein as internal health-relatedparameters) indicative of a health condition. The IMD includes one ormore IMD sensors to sense one or more desired internal health-relatedparameters. In various embodiments, the IMD is capable of providingtherapy to treat the health condition. In various embodiments, thesystem includes an external health data source that includes otherhealth-related parameters (also referred to herein as externalhealth-related parameters). The external health-related parameters caninfluence the sensed internal health-related parameters. Thus, acombination of internal and external health-related parameters canprovide a more accurate view of the patient's health.

[0038] In various embodiments, the system includes a user input tocollect health-related information that is contributed voluntarily by auser (such as a patient, clinician or other user). This user-volunteeredinformation is an example of external human-resource parameters and isable to be more subjective in nature (compared to the internalhealth-related parameters determined by sensors or other externalhealth-related parameters such as databases and external sensors), andthus is useful to identify other information that can influence theother health-related parameters. The present subject matter acquiresinternal and/or external health-related parameters from one or more ofthese sources, trends the parameters, and displays the trendedparameters in a useful manner on a wellness monitoring device to assistwith accurately assessing and treating a patient's health condition. Assuch, the present subject matter is capable of providing a diagnosticcontext used to interpret the health condition of the patient, and toappropriately adjust the device and/or medical therapy, accordingly.

[0039] A large number of health-related parameters are capable of beingacquired, trended and displayed according to various embodiments of thepresent subject matter. For example, a non-exhaustive list ofhealth-related parameters includes heart rate/rhythm includingventricular tachycardia and fibrillation, conduction intervals, ectopicdensity, atrial fibrillation (AF)/atrial tachycardia (AT) percent, heartrate variability (HRV), activity, lead position, concomitant conditions,temperature, blood pressure, respiration rate/rhythm,pulmonary/peripheral edema, posture, blood gases, stroke volumecontractility, filling time, heart sounds, weight, ischemia, cardiacoutput, after load, medications, device indications, and electromyogram.Other examples of health-related parameters are provided throughout thisdisclosure.

[0040] These health-related parameters are capable of being acquiredfrom a number of data sources. For example, a non-exhaustive list ofdata sources include IMDs, external device sensors, medication usagemonitors, databases, and user inputs by a clinician and/or patient. AnIMD, for example, is capable of providing health-related parameters forrhythms, conduction delays, respiration, activity, heart sounds,posture, and the like. External device measurements, for example, arecapable of providing health-related parameters for weight, bloodpressure, echo pulse oximetry, peripheral edema, and the like. Otherexamples of IMD health-related parameters and external health-relatedparameters are provided throughout this disclosure. A physician, forexample, is capable of providing health-related parameters for leadpositions, indications(s), medications, concomitant conditions, and thelike. A medical database, for example, is capable of providinghealth-related parameters from external device measurements andphysician input for medical tests and a large number and a large varietyof other parameters. A patient, for example, is capable of providinghealth-related parameters for diet, medication usage, symptoms, bloodpressure, and the like. As technology continues to improve, more andmore health-related parameters will be automatically acquired using, forexample, an IMD rather than using an external interactive system.

[0041] In various embodiments of the present subject matter, the APMsystem performs various methods related to managing a patient's health.The APM system includes a number of programmable devices with amachine-readable medium having machine-executable instructions. Theprogrammable devices(s) perform the machine-executable instructions toperform the method. In various embodiments, the programmable deviceincludes a processor to perform the machine-executable instructions. Invarious embodiments, the machine-executable instructions are provided onone or more machine-readable mediums (or media).

[0042]FIG. 1 illustrates an advanced patient management system accordingto various embodiments of the present subject matter. Variousembodiments of the system 100 include less than all of the componentsshown in FIG. 1, and various embodiments of the system 100 include othercomponents than those shown in FIG. 1.

[0043] A patient 101 is illustrated with an implantable medical device(IMD) 102. Generally, the IMD includes one or more IMDs that provideinternal therapy and/or acquire or sense internal data parameters. Invarious embodiments, the IMD is a CRM device that provides cardiacrhythm management pulsing and also senses one or more physiologicalparameters of a heart. Other IMDs that sense parameters and/or providetherapy, including various electrical and drug therapy, are within thescope of the present subject matter.

[0044] In various embodiments, at least one IMD 102 provides internaldata such as heart rhythm, breathing, and activity. Other types of dataderived from IMDs are also contemplated. For example, in one embodiment,a respiration sensor is implanted into patient and communicates withportable device. Data received from such IMDs may be perceived asinvoluntary, or passive, data since the patient has no control over theprocess of collecting and transmitting the data from such sources. Invarious embodiments, IMD-provided data includes parameters sensed by theIMD and/or parameters provided by interrogating the IMD to obtain deviceperformance status.

[0045] The illustrated system also includes one or more external datasource(s) 103 that provide health-related parameters. The externalhealth-related parameters supplement the internal parameters and/orprovide a diagnostic context to the internal health-related parameters.Examples of external source(s) of health data include: external sensingdevices such as body temperature thermometers, blood pressure monitors,and the like; room temperature thermometers, light sensors and the like;databases such as patient history databases that are found hospitals orclinics and that may include information such as medical test resultsand family history; a web server database (a database accessible througha global communication network—e.g. Internet) that may includeinformation regarding environment, medication interaction, and the like;databases and/or user inputs regarding mental/emotional and dietparameter types; and other external data sources capable of providinghealth-related parameters. One definition of the term mental issomething that is of or relates to the mind. One definition of the termemotional is a strong feeling, aroused mental state, or intense state ofdrive or unrest, which may be directed toward a definite object and isevidenced in both behavior and in psychologic changes, with accompanyingautonomic nervous system manifestations.

[0046] The illustrated system also includes a user input 104 throughwhich a user is able to input additional health-related parameters foruse by a wellness monitoring device (WMD) 105. In various embodiments,the user input 104 includes a touch screen on a PDA or other device, akeyboard and mouse on a computer, and the like. In various embodiments,a patient is able to input additional health-related parameters for useby the wellness monitoring device. In various embodiments, a clinicianis able to input additional health-related parameters for use by theWMD.

[0047] The WMD 105 is illustrated by dotted line, and includes one ormore devices. In various embodiments, the at least one IMD 102communicates wirelessly with at least one WMD 105, as shown bycommunication link 106. In various embodiments that include multipleWMDs, the WMDs are able to communicate with each other, as shown viacommunication link 107. In various embodiments, the WMD(s) includesportable devices 108 that are external to the body of patient such as aPDA, (variously referred to as a personal digital, or data, assistant),a portable telephone (including a cellular telephone or a cordlesstelephone), a pager (one way or two way), a handheld, palm-top, laptop,portable or notebook computer, or other such battery operated portablecommunication device. IN various embodiments, the WMD(s) includesprogrammers. In various embodiments, the WMD(s) includes variousnon-portable devices such as larger computers or computer enterprisesystems.

[0048] In various embodiments of the present subject matter, the WMD 105(which includes one or more devices) includes a display on whichparameter trends are capable of being displayed. In various embodiments,the portable device 108 includes a touch-sensitive display screen fordisplaying information to a user or patient. Depending on theapplication executing on the portable device 108, the display screen mayprovide prompts, messages, questions, or other data designed to elicitan input from patient. Examples of such prompts are provided in thepatent application entitled “Method and Apparatus for EstablishingContext Among Events and Optimizing Implanted Medical DevicePerformance,” Ser. No. 10/093,353, filed on Mar. 6, 2002, which haspreviously been incorporated by reference in its entirety. Data receivedfrom such interactive prompts may be perceived as voluntary, or active,data since the cooperation and active input of the patient is part ofthe data collection process. In various embodiments, the user input datamay be received from a user based on a prompt provided to the user, onan ad hoc basis as determined by the user, or as determined by aprocessor. The user may enter data using a menu based system, agraphical user interface (GUI), textual data or numerical data.

[0049] The WMD provides analysis of internal and external (bothvoluntary and involuntary) parameters. In various embodiments, the WMDincludes computer and programming that conducts data analysis suitablefor use in managing patient health and medical care.

[0050]FIG. 2 illustrates an advanced patient management (APM) systemaccording to various embodiments of the present subject matter. Variousembodiments of the system 200 include all of the components shown inFIG. 2, various embodiments of the system 200 include less than all ofthe components shown in FIG. 2, and various embodiments of the system200 include other components than those shown in FIG. 2.

[0051] In the figure, the system 200 is shown to include an IMD 202. Invarious embodiments, the IMD includes an implantable cardiac device(ICD), cardiac rhythm management (CRM) device, pulse generator, or otherimplanted medical device that provides therapy to a patient or an organof a patient, and/or that provides data derived from measurementsinternal to a patient. In various embodiments, the IMD includes a deviceto provide drug therapy.

[0052] The illustrated system 200 includes at least one WMD 205 thatincludes at least one display for displaying trended parameters. In theillustrated system, the at least one WMD includes a portable device 208(such as a PDA) and a programmer 209. The IMD 202 is shown coupled tothe portable device 208 by communication link 210. The portable deviceis further coupled to the programmer by communication link 207. Variousembodiments of the present subject matter do not include the portabledevice 208. In these embodiments, the IMD 202 is able to be coupleddirectly to the programmer 209 by a communication link (not shown).

[0053] At least one external data source 203 (such as web server(s),database(s), and sensor(s)) is coupled to the WMD(s) via at least onecommunication link. The external data source 203 provides external (withrespect to the IMD in the patient) health-related parameters thatsupplement and/or provide context for the IMD parameters. In theillustrated system, a communication link 211 exists between the portabledevice 208 and the external data source 203, and a communication link212 exists between the programmer 209 and the external data source 203.It is noted that various applications may not require both communicationlinks 211 and 212. In the illustration, the system 200 includes at leastone user input 204 to the at least one WMD 205. For example, a patientis able to provide health-care information using the portable device208, and a health care provider is capable of providing health-careinformation using the programmer 209.

[0054] In various embodiments, the IMD also includes circuitry andprogramming adapted to monitor the condition and performance of thepulse generator or other IMD. For example, in various embodiments, theIMD provides data concerning the remaining battery condition for a powersupply coupled to the IMD. Such data may include information regardingremaining battery capacity or life, battery internal resistance or othermeasurable parameters. In various embodiments, the data includesinformation regarding the electrical therapy provided by the IMD. Forexample, in various embodiments, such data includes lead impedance,sense voltage levels, therapy history, and device therapy mode settingsand parameter values. In various embodiments, the IMD provides dataregarding dosage, timing and other functions regarding the delivery of adrug therapy or other therapy. For example, in various embodiments, theIMD monitors blood sugar levels and the amount and timing of insulindelivered to the patient.

[0055] In various embodiments, the IMD includes a program executing onan internal processor that controls the operation of the IMD. Theprogram instructions reside in a memory accessible to the internalprocessor. By changing the program, or memory contents, the presentsystem allows the operating program of the IMD to be dynamicallytailored to a particular patient or condition. In various embodiments,the operating system, or memory contents of the IMD is changed usingwireless communication.

[0056] In various embodiments, the IMD includes a wireless transceiver.The transceiver operates using radio frequency transmissions,electromagnetic transmissions, magnetic coupling, inductive coupling,optical coupling, or other means of communicating without need of a wireconnection between the IMD and another transceiver.

[0057] In various embodiments, the IMD performs a data acquisitionfunction. In various embodiments, the IMD is adapted to monitor a fluidpressure, such as blood or urine. In various embodiments, the detectoris adapted to monitor respiration, stress level, or other measurablebiometric parameter. In various embodiment, monitoring includesdetermining an absolute or relative value for a particular biometricparameter. In various embodiments, internal memory within the IMD storesa comparison value which may then be compared with a measured valuethereby determining the performance of the IMD or the health of thepatient.

[0058] In various embodiments, the communication link includes awireless communication link between the IMD and portable device. Thecommunication link allows communication in one or two directions.

[0059] In various embodiments, data from the IMD is communicated toportable device with no data transmitted from portable device to theIMD. In this manner, portable device functions as a data storagefacility for the IMD. In various embodiments, data stored in portabledevice is accessed by a treating physician and used for diagnosis,therapy or other purposes. Programming and controlling the operation ofthe IMD is performed using a programmer adapted to transmit commands,data or code to the IMD. In various embodiments, portable deviceexecutes programming to analyze and process the data received from theIMD. In various embodiments, communication link precludes transfer ofdata from portable device to the IMD or precludes transfer of data fromthe IMD to portable device. For example, it may be desirable in certaincircumstances to prevent the portable device from executing programmingto automatically adjust the performance or operation of the IMDindependent of a programmer.

[0060] In various embodiments, data is communicated from portable deviceto the IMD with no data transmitted from the IMD to portable device. Inthis manner, portable device functions as an interface to communicatecommands, data or code to the IMD. In various embodiments, data iscommunicated from the IMD to the portable or external device with nodata transferred from the device to the IMD.

[0061] In various embodiments, data is communicated bidirectionallybetween the IMD and the portable device. In various embodiments, thecommunication link between the IMD and the portable device entails asingle bidirectional communication channel or includes multipleunidirectional communication channels which, when viewed as a whole,provide bidirectional communication. In various embodiments, aunidirectional communication channel operates using a particularfrequency or communication protocol. For example, the link may include awireless radio frequency link compatible with a transmitter and receiverthat uses frequency hopping, spread spectrum technology.

[0062] In various embodiments, internal memory within the IMD providesstorage for data related to the IMD-provided therapy (such as CRMtherapy provided to a heart). For example, the data can relate to theelectrical, chemical or mechanical operation of the heart. In addition,the IMD includes memory for programming, comparison and other functions.In various embodiments, the contents of the memory regulates theoperation of the IMD.

[0063] In various embodiments, the portable device 208 includes orotherwise is incorporated or in communication with a battery operatedportable communicator having a processor, memory, and an outputinterface to communicate with a user and an input interface to receiveuser entered data. One suitable example of a portable communicator isthat of a personal digital assistant (PDA). PDA devices typicallyinclude a display screen for presenting visual information to a user anda writing surface for entry of data using a stylus. Data can be enteredusing a keyboard coupled to the portable communicator or by means of awired or wireless communication link. Some portable communicator modelsalso include an audio transducer, or sound generator, adapted to producesounds that are audible by a user.

[0064] In various embodiment, data from the IMD or the programmer isdisplayed on a display or screen of the portable device.

[0065] In various embodiments, the portable device 208 includes orotherwise is incorporated or in communication with a portable telephone(such as a cellular telephone or a cordless telephone), a pager (one wayor two way), or a computer (such as a handheld, palm-top, laptop, ornotebook computer) or other such battery operated, processor based,portable communication device.

[0066] In various embodiments, the portable device 208 includes datastorage and includes programming and instructions to conduct dataprocessing. In various embodiments, the data storage capacity of theportable device 208 augments the data storage capacity of the IMD 202,thus enabling a clinician to access a greater amount of multi-relatedinformation regarding the medical condition of a user. For example, butnot by way of limitation, the additional information may assist indiscovering and understanding relationships among different events.

[0067] In various embodiments, a wireless receiver is coupled to aportable device for purposes of receiving data from the IMD 202 throughcommunication link 210. In various embodiments, a wireless transmitteris coupled to the portable device for purposes of transmitting data tothe IMD. In various embodiments, a wireless transceiver is coupled tothe portable device for purposes of both transmitting data to, andreceiving data from, the IMD. In various embodiments, the portabledevice includes telemetry to facilitate wireless communications.

[0068] In various embodiments, circuitry or programming allows theportable device 208 to trigger an alarm under predetermined conditions.In various embodiments, for example, the portable device sounds anaudible alarm or transmits an alarm signal if a biometric parameterexceeds a particular value or is outside a specified range of values.The alarm signal can be received by the programmer 209 or a designatedphysician.

[0069] Communication link 207 couples the portable device 208 with theprogrammer 209. In various embodiments, communication link 207 includesa wired or wireless link that allows data communication between portabledevice and the programmer. In various embodiments, data is exchangedbetween portable device and the programmer by means of a removablestorage media.

[0070] In various embodiments, the programmer 209 includes a processorbased apparatus that executes programming to communicate with the IMD202, the portable device 208, or both. A clinician (e.g. physician) canoperate the programmer to communicate with the IMD using 202 portabledevice as a data interface. In particular, various embodiments providethat data from the IMD 202 can be retrieved by accessing the memory ofportable device 208. In various embodiments, the programmer 209transmits data to the IMD 202 via the portable device 208.

[0071] In various embodiments, at least one of the WMDs includes adisplay. FIG. 2 illustrates a system in which the portable device 208includes a display and the programmer 209 includes a display. Accordingto various embodiments of the present subject matter, health-relatedparameters are displayed on the display(s) of the wellness monitoringdevice(s). In various embodiments, these health-related parameters areacquired via an IMD and/or via an external source such as user inputand/or external health data sources such as databases and the like.According to various embodiments of the present subject matter, trendedhealth-related parameters, predetermined events, alerts and/or otherinformation provided in this disclosure are displayed on the wellnessmonitoring device(s).

[0072]FIG. 3 illustrates an advanced patient management (APM) systemhaving direct communication links according to various embodiments ofthe present subject matter. According to various embodiments of thesystem 300, the communication links include wired links, wireless linksor both wired and wireless links. Various embodiments include all of thecomponents shown in FIG. 3, various embodiments include less than all ofthe components shown in FIG. 3, and various embodiments include othercomponents than those shown in FIG. 3.

[0073] The illustrated system 300 includes at least one IMD 302, atleast one external source of health data 303, and at least one WMD 305with a display 313. The illustrated system includes a user input 304 tocommunicate with the WMD. The illustrated system includes acommunication link 314 between the IMD(s) 302 and the external source(s)of health-related data 303, a communication link 315 between theexternal source(s) of health-related data 303 and the WMD(s) 305, and acommunication link 316between the IMD(s) 302 and the WMD(s) 305. It isnoted that various embodiments include less than all of thecommunication links. For example, in various embodiments data from theexternal source(s) of health data is not communicated to IMD(s) throughlink 314, and in various embodiments data from the external source(s) ofhealth data is communicated to the wellness monitor device(s) throughthe IMD(s) and links 314 and 316. Various embodiments implement variouscommunication designs to achieve various data flow.

[0074] In various embodiments, the display 313 of the WMD(s) is used todisplay trended parameters, such as internal parameters from the IMD(s)and external parameters for the external source(s) of health-relateddata. Other information can be displayed, as is provided throughout thedisclosure. Furthermore, a user is able to input additional externalhealth-related information via user input. In various embodiments, theWMD(s) include a portable device such as a PDA, laptop computer, cellphone, and the like. In various embodiments, the WMD(s) include otherexternal devices such as bedside monitors, desktop computers, IMDprogrammers, and the like.

[0075]FIG. 4 illustrates an advanced patient management (APM) systemhaving network communication links according to various embodiments ofthe present subject matter. According to various embodiments, thecommunication links include wired links, wireless links or both wiredand wireless links. Various embodiments include all of the componentsshown in FIG. 4, various embodiments include less than all of thecomponents shown in FIG. 4, and various embodiments include othercomponents than those shown in FIG. 4.

[0076] The illustrated system 400 includes at least one IMD 402, atleast one external source of health data 403, at least one WMD 405 witha display 413, and at least one network infrastructure through which theother devices (also referred to within this discussion as networkdevices) are capable of communicating. The illustrated system includes auser input 404 to communicate with the WMD 405. In various embodiments,the WMD(s) includes a portable device such as a PDA, laptop computer,cell phone, and the like. In various embodiments, the wellness monitordevice(s) include other external devices such as bedside monitors,desktop computers, IMD programmers, and the like. Examples of a networkcommunication link includes, but is not limited to, one or more of thefollowing: cellular telephone coupled to a portable device via theInternet, a private area branch exchange (PABX, also known as a PBX); anintranet network; an ethernet connection or other remote communicationmeans.

[0077] The illustrated system includes a communication link between theIMD(s) 402 and the external source(s) of health-related data 403 via thenetwork 417, a communication link between the external source(s) ofhealth-related data 403 and the WMD(s) 405 via the network 417, and acommunication link between the IMD(s) and the WMD(s) 405 via the network417. The illustrated system includes a network interface or adapter 418.The network adapter 418 wirelessly communicates with the IMD 402 viacommunication link 419, and communicates with network devices throughnetwork via communication link 420. Although not expressly, othernetwork devices include a network interface.

[0078] Various embodiments include a direction communication link asillustrated in FIG. 3 and a network communication link as illustrated inFIG. 4. The display of the WMD(s) is used to display trended parameters,such as internal health-related parameters from the IMD(s) and externalhealth-related parameters for the external source(s) of health-relateddata. Furthermore, a user is able to input additional externalhealth-related information via user input.

[0079]FIG. 5 illustrates an advanced patient management (APM) systemhaving network communication links according to various embodiments ofthe present subject matter. Various embodiments include all of thecomponents shown in FIG. 5, various embodiments include less than all ofthe components shown in FIG. 5, and various embodiments include othercomponents than those shown in FIG. 5.

[0080] The illustrated system 500 includes at least one IMD 502, atleast one external source of health data 503, at least one WMD 505 witha display 513, and at least one network infrastructure 517 through whichthe other devices (also referred to within this discussion as networkdevices) are capable of communicating. The illustrated system 500 alsoincludes direct communication connections 521 between the IMD(s) 502 andthe external source(s) of the health data 503, and between the WMD(s)505 and the IMDS(s) 502. One of ordinary skill in the art willunderstand, upon reading and comprehending this disclosure, that variousembodiments include some direct communication connections between somecomponents and include some network communication connections betweensome components.

[0081] The illustrated external source(s) of health data 503 include atleast one external sensing device 522 such as a body temperature orblood pressure monitor, at least one patient history database 523, atleast one web server 524, and other external sources 525. Variousembodiments of the present subject matter include one or more of theillustrated external sources of health data. The illustrated WMD(s)includes a programmer 509 with a display, a portable device 508 (such asa PDA or laptop computer) with a display, or other WMD(s) 526 with adisplay. Various embodiments of the present subject matter include oneor more of the illustrated WMDs.

[0082]FIG. 6 illustrates a perspective view of an advanced patientmanagement (APM) system that includes an IMD 602 and a portable device608 such as a PDA. The illustrated portable device 608 includes adisplay screen 627, a plurality of user operable buttons 628, and anexpansion port 629 which receives and is coupled to an expansion device630 that is designed to communicate with the IMD 602. In variousembodiments, a specially designed portable device is employed with anintegrated communication subsystem. A stylus 631 can be used to manuallyenter data using screen. Link 606 is illustrated as a bidirectional linkand thus, data from IMD 602 is wirelessly telemetered to the portabledevice 608 through the expansion device 630. In addition, data, orprogramming from the portable device 608 is wirelessly telemetered fromthe expansion device 630 to the IMD 602.

[0083] According to various embodiments, the portable device (such asthe illustrated PDA) generates a prompt at various times calling for aresponse in the form of a user input. A user may enter data using any ofa variety of means. For example, a response may be entered using stylus,buttons, or an external keyboard. In one embodiment, portable deviceresponds to voice commands received from a user. A prompt may bevisually displayed using screen or audibly generated using an internalsound generator. Manually entered data received from a user, as well asdata received from other inputs is stored using the portable device. Thedata stored in the portable device is available for processing, and totailor the therapy.

[0084] In addition to data entry, the portable device 608 provides auser with limited control over the operation of an IMD 602 in variousembodiments. In various embodiments, reasonable constraints on theauthority to change the operation of IMD are established and implementedby a clinician.

[0085]FIG. 7 illustrates a perspective view of an advanced patientmanagement (APM) system that includes an IMD 702, a portable device 708such as a PDA, and another WMD 732, such as a programmer for the IMD,networked to the PDA. The illustrated portable device includes awireless communication antenna 733. In various embodiments, the portabledevice 708 is adapted for wireless access to Internet network using link734. In various embodiments, link 734 includes a radio frequencycommunication link. The programmer accesses the Internet via link 735.In various embodiments, 735 link includes a dial-up modem connection, acable modem connection, a DSL connection, an ISDN line, or other channelproviding access to the Internet.

[0086] A user is able to compile contextual information regarding IMD702, as well as himself, using the portable device 708. In variousembodiments, a clinician using the programmer 732 is able to remotelyaccess the data stored in the portable device 708 using link 735,Internet and link 734. In this manner, programmer 732 is able towirelessly receive the data, process the data, and transmit data andcode to change the future operation of the IMD 702.

[0087]FIG. 8 illustrates a perspective view of an advanced patientmanagement (APM) system that includes an IMD 802, a portable device suchas a PDA 808, and another WMD 832, such as a programmer for the IMD,directly connected to the PDA. The PDA is coupled to IMD by wirelesslink 836, and is further coupled to programmer by link 837 (illustratedas a communication cable).

[0088] A clinician operating programmer 832 is able to exchange data orcode with the PDA 808 using link 837. Connector is a multi-conductorconnector providing access to data of the PDA. It will be appreciatedthat link may couple the PDA to a local area network or othercommunication network. For example, the PDA may be connected to a publicswitched telephone network (PSTN) link, and thus, programmer mayexchange data with portable communicator using a modem coupled to PSTN.

[0089]FIG. 9 illustrates a block diagram of an IMD according to variousembodiments of the present subject matter. The illustrated IMD 902includes a processor 938, memory 939, an update module 940 and atransceiver 941. In operation, the processor governs the operation ofIMD and executes programming stored in memory. In addition to theexecutable program, memory also includes data storage regarding thepatient and IMD. The update module operates in conjunction withprocessor, memory and transceiver to receive, install, and execute newinstructions for execution by processor.

[0090]FIG. 10 illustrates a block diagram of a WMD, such as a portabledevice, a programmer and the like, according to various embodiments ofthe present subject matter. The illustrated WMD 1005 includes long termdata storage 1042, an input/output 1043, a controller 1044, an IMDtransceiver 1045, a communication interface 1046 and a display 1047. Thelong term data storage augments the data storage capacity of the memoryof the IMD. In various embodiments, the storage is of a greater capacitythan that of memory, is physically larger in size, and is less expensiveand more robust than medical grade implantable memory.

[0091] The input/output, the IMD transceiver and the communicationinterface, in conjunction with the controller enables receipt andtransmission of data from the IMD as well as data from other sourcessuch as other WMDs, databases and the like. The IMD transceiver providesa wireless communication link between the IMD and the portable device.The display is used to, among other things, display parameters that havebeen acquired and trended by the system according to the present subjectmatter.

[0092]FIG. 11 provides a brief, general description of a suitablecomputing environment in which the above embodiments may be implemented.The illustrated computing environment, or portions thereof, can beimplemented in a WMD. Additionally, portions of the illustratedcomputing environment (such as the system memory and processor) can beimplemented in IMDs.

[0093] Embodiments of the present subject matter can be described in thegeneral context of computer-executable program modules containinginstructions executed by a computing device. The term module includeshardware, firmware, software, and various combinations thereof toperform task(s) described in this disclosure, as is understood by one ofordinary skill in the art upon reading and comprehending thisdisclosure. Program modules include routines, programs, objects,components, data structures, etc. that perform particular tasks orimplement particular abstract data types. Those skilled in the art willappreciate that the invention may be practiced with othercomputer-system configurations, including hand-held devices,multiprocessor systems, microprocessor-based programmable consumerelectronics, network PCs, minicomputers, mainframe computers, and thelike which have multimedia capabilities. The invention may also bepracticed in distributed computing environments where tasks areperformed by remote processing devices linked through a communicationsnetwork. In a distributed computing environment, program modules may belocated in both local and remote memory storage devices.

[0094]FIG. 11 illustrates various embodiments of a WMD in the form of ageneral-purpose computing device. One of ordinary skill in the art willunderstand, upon reading and comprehending this disclosure, how toimplement the present subject matter using other WMDs and IMDs with someof the illustrated components or other components.

[0095] The illustrated computing device 1148 includes a processing unit1149, a system memory 1150, and a system bus 1151 that couples thesystem memory and other system components to processing unit. The systembus may be any of several types, including a memory bus or memorycontroller, a peripheral bus, and a local bus, and may use any of avariety of bus structures. The system memory includes read-only memory(ROM) and random-access memory (RAM). A basic input/output system(BIOS), stored in ROM, contains the basic routines that transferinformation between components of personal computer. BIOS also containsstart-up routines for the system. Various embodiments of the computingdevice further include a hard disk drive for reading from and writing toa hard disk (not shown), a magnetic disk drive for reading from andwriting to a removable magnetic disk, and an optical disk drive forreading from and writing to a removable optical disk such as a CD-ROM orother optical medium. Hard disk drive, magnetic disk drive, and opticaldisk drive are connected to system bus by a hard-disk drive interface, amagnetic-disk drive interface, and an optical-drive interface,respectively. The drives and their associated computer-readable mediaprovide nonvolatile storage of computer-readable instructions, datastructures, program modules and other data for the computing device.Those skilled in the art will appreciate that other types ofcomputer-readable media which can store data accessible by a computermay also be used.

[0096] Program modules can be stored on the hard disk, magnetic disk,optical disk, ROM and RAM. Program modules may include operating system,one or more application programs, other program modules, and programdata. A user may enter commands and information into personal computerthrough input devices such as a keyboard and a pointing device. Theseand other input devices are often connected to the processing unitthrough a serial-port interface coupled to system bus; but they may beconnected through other interfaces not shown in FIG. 11, such as aparallel port or a universal serial bus (USB). A monitor or otherdisplay device also connects to system bus via an interface such as avideo adapter. In addition to the monitor, personal computers typicallyinclude other peripheral output devices (not shown) such as speakers andprinters. In one embodiment, one or more speakers or other audio outputtransducers are driven by sound adapter connected to system bus.

[0097] In various embodiments the computing device operates in anetworked environment using logical connections to one or more remotedevices such as remote computer. Examples of remote computers include apersonal computer (PC), a server, a router, a network PC, a peer device,or other common network node. In various embodiments, the remotecomputer includes many or all of the components described above inconnection with the computing device; however, only a storage device isillustrated in FIG. 11 to simplify the disclosure. The logicalconnections depicted in FIG. 11 include local-area network (LAN) and awide-area network (WAN). Such networking environments exist in offices,enterprise-wide computer networks, intranets and the Internet. Thecomputing device connects to local network through a network interfaceor adapter in various embodiments, and to a WAN/Internet network througha modem or other means for establishing communications over network.

[0098] Various embodiments of the present subject matter are illustratedin FIGS. 12-27 and are discussed below. One of ordinary skill in the artwill understand, upon reading and comprehending this disclosure, thatthese embodiments are not necessarily mutually exclusive as variousembodiment can be combined or otherwise modified to create otherembodiments. One of ordinary skill in the art also will understand, uponreading and comprehending this disclosure, that various elements shownand described with respect to one or more of FIGS. 1-11 are capable ofbeing combined with various elements shown and described with respect toone or more of FIGS. 12-27.

[0099] Acquisition, Trending and Displaying Health-Related Parameters

[0100] FIGS. 12-16 illustrate various embodiments of the present subjectmatter related to acquiring, trending and displaying health-relatedparameters. In various embodiments, an IMD acquires, trends and displaysa variety of parameters pertinent to the health status of a patient.

[0101]FIG. 12 illustrates a block diagram of a device for acquiring,trending and displaying multiple health-related parameters according tovarious embodiments of the present subject matter. The device 1252acquires available parameters from available sources. In variousembodiments, the device 1252 includes a WMD such as a portable device, aprogrammer and the like. In various embodiments, the device 1252includes an IMD. For example, potentially available sources include anIMD parameter collection 1253 (internal health-related parameters suchas internal physiological measurements, applied therapy, deviceperformance, and the like), an external parameter collection 1254(external parameters such as external physiological and environmentalmeasurements, databases, and the like), and a user input parametercollection 1255 (voluntary data). User inputs can be considered to be anexternal health-related parameter. However, for purposes of thedescription with respect to FIG. 12, external parameter collection anduser input parameter collection are considered separately.

[0102] In various embodiments, the IMD parameter collection 1253includes at least one of a physical parameter type, aphysiological/pathological parameter type, a mental/emotional parametertype, a diet parameter type, an environmental parameter type, a symptomparameter type, and a medical compliance type. In various embodiments,the IMD is gathers information from an external device or sensor inorder to gather certain parameter types. Furthermore, the IMD is capableof acquiring medication compliance by monitoring a measurable parametercorrelated to compliance. For example, blood pressure is monitored toverify that a patient is compliant with hypertensive medications. TheIMD is also capable of acquiring environmental data, such as barometricpressure using an implanted pressure sensor and such as relativetemperature changes using an implanted temperature sensor near thesurface of the skin.

[0103] One definition of mental is of or relating to the mind. Onedefinition of emotional is relating to or marked by an emotion (a strongfeeling, aroused mental state, or intense state of drive or unrest,which may be directed toward a definite object and is evidenced in bothbehavior and in psychologic changes, with accompanying autonomic nervoussystem manifestations). One definition of physiological is normal, asopposed to pathologic. One definition of pathological is diseased. Otherdefinitions can be used consistently with respect to these terms.

[0104] In various embodiments, the external parameter collection 1254includes one or more of a mental/emotional parameter type, anenvironmental parameter type and a diet parameter type. In variousembodiments, the external parameter collection 1254 includes a physicalparameter type, a physiological/pathological parameter type, a symptomparameter type, and/or a medication compliance parameter type. Theexternal parameter collection can include any one or any combination ofthe above parameter types according to embodiments of the presentsubject matter.

[0105] In various embodiments, the user input parameter collection 1255includes one or more of a mental/emotional parameter type, anenvironmental parameter type and a diet parameter type. In variousembodiments, the user input parameter collection 1255 includes aphysical parameter type, a physiological/pathological parameter type, asymptom parameter type, and/or a medication compliance parameter type.The user input parameter collection can include any one or anycombination of the above parameter types according to embodiments of thepresent subject matter.

[0106] Examples of a physical parameter type include, but are notlimited to, parameters related to activity, posture, and sleep. Examplesof a mental/emotional parameter type include, but are not limited to,parameters related to stress, excitement, anger, anxiety (such as may bedetected via sighing), and depression. Examples ofphysiological/pathological parameter types include, but are not limitedto, parameters related to blood pressure, respiration rate and patterns,and medical test results. Examples of environmental parameter typesinclude, but are not limited to, parameters related to altitude,temperature, air quality, pollen count, and humidity. Examples of dietparameter types include, but are not limited to, parameters related tosodium intake, fluid intake and lipid intake. Examples of symptomparameter types include, but are not limited to, parameters related topain, dyspnea and fatigue. In various embodiments, a symptom can beconsidered to be, for example, a patient-perceived condition based onfrequency, severity and/or repetition. Examples of medication complianceparameter types include, but are not limited to, parameters related todrug administration such as drug type, dosage and time. Examples of drugtype includes insulin, beta-blockers, diuretics and the like.

[0107] Health-related parameters are acquired from various sources. Invarious embodiments, a number of parameters are acquired from IMD, andfrom external sources such as external parameter collections(programmer, web servers, patient databases, external sensors, etc.) anduser input parameter collections (answered questions, etc.). Theparameter trends are displayed in a single display area of at least oneof the WMDs.

[0108] In various embodiments, available parameters are acquired atmodule 1256. The acquired parameters are processed according to aprocedure implemented in software. In various embodiments, the softwareautomatically acquires those health-related parameters deemed to beuseful based on a potential health condition. In various embodiments,the software instructions provide a procedure, when operated on by aprocessor, which automatically determines a potential health condition,and thus additional parameters to be acquired, from previously acquiredparameters. Thus, the present subject matter is capable of automaticallyand intelligently acquiring additional parameters to confirm and/ordismiss an initial diagnosis.

[0109] In various embodiments, module 1257 includes softwareinstructions that, when operated on by a processor, provide a procedurethat automatically trends the acquired parameters. The trendingprocedure analyzes the parameters as a function of time or othermeasured parameter. In various embodiments, module 1258 allows a user toselect parameter trends to be displayed in a single display area. Module1259 is used to display representations in a single display area. Invarious embodiments in which device 1252 includes a WMD, module 1259displays the representation on a display of the WMD. In variousembodiments in which device 1259 includes an IMD, module 1259 transmitsa signal for reception by a display device to display the representationon the display device.

[0110] In various embodiments, the acquired data and trends are analyzedto select an updated program or specify updated operational parametersfor the IMD. The updated program or operational parameters are capableof being transferred and implemented by IMD.

[0111]FIG. 13 illustrates a block diagram of a wellness trending displaygenerally illustrating parameter trends available for display accordingto various embodiments of the present subject matter. In variousembodiments of the display 1360, trends associated with at least one ofa physical parameter type 1361, a physiological/pathological parametertype 1362, a mental/emotional parameter type 1363, an environmentalparameter type 1364, a diet parameter type 1365, a symptom parametertype 1366 and a medication compliance parameter type 1367 (and variouscombinations of a physical parameter type, a physiological/pathologicalparameter type, a mental/emotional parameter type, an environmentalparameter type, a diet parameter type, a symptom parameter type and amedication compliance parameter type) are available to be displayed in asingle wellness trending display area 1360.

[0112] In various embodiments, parameters available to be displayed thatare associated with a physical parameter type include, but are notlimited to, parameters related to activity, posture, and sleep. Invarious embodiments, parameters available to be displayed that areassociated with a mental/emotional parameter type include, but are notlimited to, parameters related to stress, anxiety (such as may bedetected via sighing), excitement, anger and depression. In variousembodiments, parameters available to be displayed that are associatedwith a physiological/pathological parameter type include, but are notlimited to, parameters related to blood pressure, respiration rate andpatterns, and medical test results. In various embodiments, parametersavailable to be displayed that are associated with a environmentalparameter type include, but are not limited to, parameters related toaltitude, temperature, air quality, pollen count and humidity. Invarious embodiments, parameters available to be displayed that areassociated with a diet parameter type include, but are not limited to,parameters related to sodium intake, fluid intake and lipid intake.

[0113]FIG. 14 illustrates a block diagram of a wellness trending displayillustrating an arrangement for selecting and displaying parametertrends according to various embodiments of the present subject matter.In the illustrated embodiment, the screen display 1460 of the WMDincludes a patient health trend area 1468A, a device trend area 1468B,and a trend display area 1468C. In various embodiments, the screendisplay includes a time indicator 1469 and an event identifier 1470. Theevent identifier is used to display predetermined events. In variousembodiments, significant events include events that are clinicallyimportant in themselves, those events that may trigger clinicallyimportant changes, and/or those events that explain clinically importantchanges. The illustrated screen display promotes the correlation ofvarious parameter trends to various predetermined events. Thecorrelation of various parameter trends is useful to diagnose and treatvarious health conditions.

[0114] In various embodiments, various trended parameters from thepatient health trend area and from the device trend area are capable ofbeing displayed in the trend display area. In various embodiments, auser is capable of selecting the displayed parameters and/or is capableof modifying the scale, arrangement and/or other display characteristic.

[0115] The illustrated patient health trend area 1468A includes aphysical parameter type 1461, a physiological/pathological parametertype 1462, a mental/emotional parameter type 1463, an environmentalparameter type 1464, a diet parameter type 1465, a symptom parametertype 1466 and a medication condition parameter type 1467. In variousembodiments, selecting the parameter type displays a second window forselecting a particular parameter associated with that parameter type.For example, selecting the physical parameter type button displaysavailable physical parameters for display such as activity, posture andsleep. Other embodiments provide other ways for a user to select theparameters to be displayed.

[0116] The illustrated device trend area 1468C includes parametersassociated with the device that can affect the sensed parameters or thatotherwise provide context to the sensed parameters. In variousembodiments of the present subject matter which include a pulsegenerator IMD, the device trend area includes battery impedance 1471,lead impedance 1472, and percent pacing 1473. One of ordinary skill inthe art will understand, upon reading and comprehending this disclosure,the significance of device trends such as battery impedance, leadimpedance, percent pacing and the like. One of ordinary skill in the artwill further understand, upon reading and comprehending this disclosure,the desirability of correlating device trends with the patient healthtrends.

[0117] A number of parameters trends, shown as trend 1, trend 2 . . .trend n, are capable of being displayed in the trend display area 1468B.The trends are plotted as a function of time, which is illustrated at1469. In various embodiments, and event identifier, represented at 1470,is also displayed in the trend display area. The event identifierdisplays predetermined events that occurred at various times, andassists with determining causes for changes in the displayed parametertrends.

[0118]FIG. 15 illustrates an example of a wellness trending display. Inthe illustrated embodiment, the screen display of the wellness monitordevice includes a patient health trend area 1566, a device trend area1568, and a trend display area 1567.

[0119] In the illustrated embodiment, a number of patient healthparameter trends are accessible in the patient health trend area,including mean resting heart rate trends, an activity trends, standarddeviation of averaged normal-to-normal (SDANN) interval trends, percentatrial fibrillation (AF) trends, intrinsic PR interval trends (theperiod of time from the onset of the P wave (atrial depolarization) tothe onset of the QRS complex (ventricular depolarization)), autonomicbalance trends, and mean resting respiratory trends.

[0120] SDANN is a particular measure of heart rate variability (HRV)that is based on 24 hour recordings of heartbeats. SDANN is computed bydetermining average heart rate over a given interval (e.g five (5)minute intervals), and taking the standard deviation of the heart rates.Preferably, the SDANN measure uses every interval during the dayassuming that all of the intervals provide good recordings. For example,there are 288 5-minute periods during a day. If all of the intervalsprovide good recordings, the SDANN is the standard deviation of these288 averages. However, since all of the recordings may not be goodthroughout the 24 hour day, the SDANN is computed from the good portionsof the recording.

[0121] Upon reading and understanding this disclosure, those skilled inthe art will readily understand the value of the heart rate, percentatrial fibrillation, autonomic balance, and respiratory trends in thecontext of patient wellness. The intrinsic PR interval is useful todetermine optimal cardiac resynchronization therapy in heart failurepatients.

[0122] In the illustrated embodiment, a number of device trends 1568 areaccessible in the device trend area, including percent ventricularpacing trends, atrial lead impedance trends, RV lead impedance trends,LV lead impedance trends, atrial intrinsic amplitude trends, rightventricular amplitude trends, and left ventricular amplitude trends.Upon reading and comprehending this disclosure, those skilled in the artwill readily understand the value of the parameters in assessing devicefunctionality and thereby the ability of the device to deliver propertherapy.

[0123] Labels are provided in FIG. 15 to illustrate the correlationbetween various parameter trends and various predetermined events. Forexample, programming the IMD, as indicated by the event identifier,resulted in a lower resting mean heart rate and an increased activity.U.S. Pat. No. 6,021,351, issued to Kadhiresan et al. and entitled Methodand Apparatus For Assessing Patient Well-Being, describes an example ofan activity. U.S. Pat. No. 6,021,351 is assigned to Applicant'sassignee, and is hereby incorporated by reference in its entirety. Theillustration also shows that a ventricular tachycardia (VT) shocktherapy did not significantly affect the heart rate or activity, butthat atrial fibrillation (AF>15%) significantly worsened the patient'shealth status as indicated by an increased resting mean heart rate and adecreased activity. One of ordinary skill in the art will understand,upon reading and comprehending this disclosure, that other parametersand predetermined events can be acquired and displayed to illustrate thecorrelation between various parameter trends and various predeterminedevents.

[0124]FIG. 16 illustrates a block diagram according to various aspectsof the present subject matter in which a diagnostic context is providedto assist with interpreting the health condition of the patient, and toappropriately adjust the device and/or medical therapy, accordingly. Thepatient diagnostics 1669 and the diagnostic context 1670 are capable ofbeing acquired using a variety of IMD and external sources, such asthose provided throughout this disclosure. A number of patientdiagnostics and diagnostic contexts are provided in FIG. 15, and willnot be repeated in this specification.

[0125] In the illustrated embodiment, the diagnostic context 1670 isused as an input in forming the patient diagnosis 1669. The diagnosticcontext and the patient diagnostics provide inputs to titrationalgorithms 1671, which are used to determine an appropriate devicetherapy based on the diagnosis and the context of the diagnosis. Thetitrated settings for the device therapy are implemented by the deviceat 1672. At 1673, various trends, reports and/or alerts/alarms aredetermined based on the patient diagnostics. A physician 1674 receivesthese various trends, reports and/or alerts/alarms, along with otherdata 1675 such as clinical exams, clinical data, medical history and thelike. Based on the available information, the physician is able toadjust (or titrate) the device therapy 1672 and/or the medical therapy1676.

[0126] Defining, Identifying and Using Predetermined Health-RelatedEvents

[0127] FIGS. 17-19 illustrate various embodiments of the present subjectmatter related to defining, identifying and using predeterminedhealth-related events. In various embodiments, a device such as a WMD orIMD defines, identifies, displays and triggers actions based on apredetermined health-related event. In various embodiments, thepredetermined events include significant events that are clinicallyimportant. Significant events includes those events that are clinicallyimportant in themselves (such as ventricular fibrillation), those eventsthat trigger an important change (such as loss of ventricular pacing) orthose events that explain a change (such as increased anxiety).

[0128]FIG. 17 illustrates a method for managing a patient's health bydefining, detecting and using predetermined health-related events,according to various embodiments of the present subject matter. At 1777,predetermined events are defined. In various embodiments, predeterminedevents are significant health-related events, such as events that areclinically important in themselves, events that trigger a change, and/orevents that explain a change. Examples of predetermined events includesdevice (e.g. IMD) therapy changes initiated by the device and/orclinician, a drug therapy change initiated by the device and/orclinician, arrhythmic events, changes in trended parameters, andautonomously-identified parameter correlations.

[0129] At 1778, predetermined health-related events are detected basedon health-related parameters. In various embodiments, the health-relatedparameters are acquire through IMD sensors, external sensors, externaldata sources such as patient databases, and/or manual data inputs. At1779, the detected event is recorded in a time log. In variousembodiments, a time stamp is associated with the event to record thetime to of the event.

[0130] At 1780, an action is triggered based on the detected events. Invarious embodiments, the triggered action includes a change in devicetherapy, an alarm and/or a display or report of the predetermined eventsalong with trended health-related parameters. In various embodiments,the triggered action includes initiating a signal for use within thedevice(s) that detected the events for transmission for use by otherdevice(s).

[0131]FIG. 18 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of detecting predeterminedhealth-related events, according to various embodiments of the presentsubject matter. The illustrated device includes a parameter acquisitionmodule 1881 to acquire health related parameters. These health-relatedparameters can include IMD parameters (whether sensed or deviceinterrogated), and parameters from external data sources such as sensorsand databases. Various embodiments acquire various health-relatedparameters that are provided throughout this disclosure. The illustrateddevice 1852 further includes a predetermined event detection module incommunication with the parameter acquisition module. The predeterminedevent detection module 1882 communicates with the parameter acquisitionmodule 1881 to determine whether the health-related parameter(s)correspond to at least one of the number of predetermined events. Theillustrated device further includes an action trigger module 1883 tocommunicate with the predetermined event detection module and trigger atleast one action appropriate for a detected predetermined event.

[0132]FIG. 19 illustrates a wellness monitoring device (WMD) formonitoring a patient's health condition that is capable of detectingpredetermined health-related events, according to various embodiments ofthe present subject matter. The illustrated device 1952 includes acommunication module 1984, a parameter acquisition module 1981, an inputmodule 1985, a predetermined event definition module 1986, a timermodule 1987 and a predetermined event detection module 1982. Inoperation, the modules perform the functions as described below.

[0133] The communication module 1984 receives at least onehealth-related parameter. The parameter acquisition module 1981communicates with the communication module to acquire the at least onehealth-related parameter. The input module 1985 receives manual inputdata, such as data for defining predetermined events and/or parametersto be acquired by the parameter acquisition module 1981 through acommunication link. The predetermined event definition module 1986communicates with the input module 1985 and/or a memory storage thatcontains a set of predetermined health-related events 1988 to define anumber of predetermined events for the patient's health condition. Thepredetermined event detection module 1982 communicates with theparameter acquisition module 1981 and the predetermined event definitionmodule 1986 to determine that the health-related parameter(s) correspondto at least one of the number of predetermined events. The predeterminedevent detection module 1982 further communicates with the timer module1987 to associate a time with the at least one of the number ofpredetermined events.

[0134] Various embodiments of the present subject matter include anaction trigger module 1983 in communication with the predetermined eventdetection module. The action trigger module 1983 is adapted to trigger adesired action based on a detected predetermined event. In variousembodiments, the action trigger is adapted to provide a signal todisplay the detected predetermined event along with a trend for the atleast one health related parameter. In various embodiments, the deviceincludes a display on which the predetermined event and the trend forthe at least one health related parameter are displayed. In variousembodiments, the signal is transmitted to another device with a displayon which the predetermined event and the trend for the at least onehealth related parameter are displayed. In various embodiments, theaction trigger is adapted to provide a signal to send an alarm inresponse to the detected predetermined event. Various embodiments of thepresent subject matter include an action trigger to provide a signal tochange device therapy in response to the detected predetermined event.

[0135] The health-related parameters acquired by the parameteracquisition module 1981 are capable of including IMD parameters orhealth-related parameters from an external data source such as externalsensors, patient history databases, databases accessible through aglobal computer network (e.g. Internet), and user inputs (e.g. manualinputs from a patient and/or clinician).

[0136] Reporting Multiple Health-Related Parameters

[0137] FIGS. 20-21 illustrate various embodiments of the present subjectmatter related to reporting multiple health-related parameters. Variousembodiments of the present subject matter provide a number of methodsfor transferring trended data, predetermined events and alerts to aclinician. In various embodiments, this type of information is capableof being displayed on a programmer screen or being otherwise used by aWMD and/or IMD within an advanced patient management system, such asthose described within this disclosure, for example. This information isfiltered in various embodiments of the present subject matter such thatonly the most relevant or clinically useful information is displayed orotherwise used.

[0138]FIG. 20 illustrates a method for reporting multiple parametersrelated to a health condition of a patient, according to variousembodiments of the present subject matter. At 2088, a number of trendedhealth-related parameters are acquired. In various embodiments, thetrended health-related parameters include any of the various parametersdescribed within this disclosure. In various embodiments, acquiring thetrended health-related parameters includes acquiring parameters andtrending the acquired parameters. At 2089, a number of predeterminedevents are acquired. In various embodiments, the predetermined eventsinclude events that are clinically important in themselves, events thattrigger a change, or events that explain a change. In variousembodiments, acquiring predetermined events include determining that theevent is a significant health-related event as provided elsewhere inthis disclosure. At 2090, a number of alerts are acquired. In variousembodiments, acquiring alerts includes determining alerts. Alerts invarious embodiments of the present subject matter includedevice-initiated alerts, patient-initiated alerts, andclinician-initiated alerts. Additionally, alerts in various embodimentsof the present subject matter include alerts directed to the patient andalerts directed to a clinician.

[0139] At 2091, the present subject communicates at least one of theparameters, events and/or alerts. Various embodiments prioritize orcharacterize the relevance of the parameters, events and/or alerts, andappropriately communicate the information according to the relevance ofthe information. In various embodiments, the parameters, events and/oralerts are communicated in a report-like manner. Various embodiments ofthe present subject matter communicate the parameters, events and/oralerts incorporating a variety of communication technologies provided inthis disclosure. In various embodiments, the communication displayingthe parameters, events and/or alerts, providing an alarm signal withrespect to the parameters, events and/or alerts, transmitting an e-mail,transmitting a telefax, placing a telephone call, and conductingwireless communication.

[0140]FIG. 21 illustrates a wellness monitoring device (WMD) formonitoring a patient's health condition that is capable of prioritizingcommunication of health-related parameters, according to variousembodiments of the present subject matter. The illustrated device 2152includes a communication module 2184, a parameter acquisition module2181, an input module 2185, a predetermined event definition module2186, a timer module 2187, a predetermined event detection/acquisitionmodule 2182, and an alert acquisition module 2192. In operation, themodules perform the following functions. The communication module 2184receives at least one health-related parameter. The parameteracquisition module 2181 communicates with the communication module 2184to acquire the at least one health-related parameter. The input module2185 receives manual input data, such as data for defining predeterminedevents and/or parameters acquired by the parameter acquisition module2181 through a communication link. The predetermined event definitionmodule 2186 communicates with the input module 2185 to define a numberof predetermined events for the patient's health condition. Thepredetermined event detection/acquisition module 2182 communicates withthe parameter acquisition module 2181 and the predetermined eventdefinition module 2186 to determine that the health-related parameter(s)correspond to at least one of the number of predetermined events. Thepredetermined event acquisition module 2182 further communicates withthe timer module 2187 to associate a time with the at least one of thenumber of predetermined events. The alert acquisition module 2192communicates with the predetermined event acquisition module 2182 andwith an alert definition module 2193 to determine alerts from, amongother things, the acquired predetermined events.

[0141] Various embodiments of the present subject matter include anoutput communication module 2194 in communication with the alertacquisition module 2192, the predetermined event acquisition module 2182and the parameter acquisition module 2181. In various embodiments, theoutput communication module 2194 is in communication with a priorityfilter 2195 for characterizing or classifying the relevance of theparameter(s), event(s) and/or alert(s). The output communication module2194 is adapted to appropriately communicate the parameter(s), event(s)and/or alert(s) using various communication technologies based on theirrelevance.

[0142] One of ordinary skill in the art will understand, upon readingand comprehending this disclosure, how to acquired parameters, eventsand/or alerts using an IMD, and transmitting a communication signalrepresented the acquired parameters, events and/or alerts from the IMDto assist with managing a patient's health.

[0143] Environmental Data

[0144]FIG. 22 illustrates various embodiments of the present subjectmatter related to reporting environmental data. Various embodiments ofthe present subject matter automatically acquire and presentenvironmental data to the attending physicians and/or patients fordisease diagnosis and therapy decision making. For example, chronicallyill patients can be very sensitive to the environment changes such asair quality and temperature. Patients who have respiratory disorderssecondary to cardiovascular diseases (e.g. HF) may be vulnerable tocertain environmental conditions. For example, acute exacerbationsometimes can be attributed to environmental changes. In variousembodiments, a device (such as an IMD and/or WMD) is able toautomatically acquire environmental data and provide such information incorrelation to other measurements of the patient conditions to theclinician and/or patient.

[0145]FIG. 22 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of synthesizingenvironmental parameters with implantable medical device (IMD)parameters, according to various embodiments of the present subjectmatter. Examples of environmental parameter types include, but are notlimited to, parameters related to altitude, temperature, air quality,pollen count, and humidity. The illustrated device 2252 includes a firstcommunication module 2296 for receiving IMD parameters, and a secondcommunication module 2297 for receiving environmental parameters from asource of environmental parameters (such as an external sensor or adatabase). The device includes a correlation module 2298 that receivesthe IMD parameter(s) and the environmental parameter(s), and correlatesthe environmental parameters with the IMD parameters.

[0146] Various embodiments of the present subject matter include anaction trigger module 2283 in communication with the correlation module2298. The action trigger module 2283 is adapted to trigger a desiredaction based on the IMD parameter(s) and the environmental parameter(s).In various embodiments, the action trigger module 2283 is adapted toprovide a signal to display the correlation between the IMD parameter(s)and the environmental parameter(s).

[0147] In various embodiments, the device 2252 includes a display onwhich the correlation between the IMD parameter(s) and the environmentalparameter(s) is displayed. In various embodiments, the signal istransmitted to another device with a display on which the correlationbetween the IMD parameter(s) and the environmental parameter(s) isdisplayed. In various embodiments, the action trigger is adapted toprovide a signal to send an alarm in response to the correlation betweenthe IMD parameter(s) and the environmental parameter(s). Variousembodiments of the present subject matter include an action triggermodule 2283 to provide a signal to change device therapy in response tothe correlation between the IMD parameter(s) and the environmentalparameter(s).

[0148] In various embodiments, the device 2252 further includes a thirdcommunication module 2299 to receive IMD position parameters. Thus, forexample, in an embodiment in which the second communication module isaccessing environmental parameter(s) from a database of regionalenvironmental parameters, the present subject matter is capable ofdetermining the appropriate region for which to retrieve environmentalparameters. Additionally, in various embodiments, the IMD positionparameters include parameters indicative of altitude. According tovarious embodiments, the IMD position parameters are generated usingcellular technology to determine a cell region, GPS technology, andmanual data inputs.

[0149] Various embodiments of the present subject matter relate to anadvanced patient management system. In various embodiments, the systemincludes at least one implantable medical device (IMD) to acquire atleast one IMD parameter indicative of patient wellness, means to acquireat least one environmental parameter from at least one external source,and means to factor in the at least one environmental parameter in theadvanced patient management system. In various embodiments, theenvironmental parameter is factored in by adjusting the IMD parameterbased on the at least one environmental parameter. In variousembodiments, the environmental parameter is factored in by adjusting adisplay of the IMD parameter. In various embodiments, the environmentalparameter is factored in by adjusting IMD-provided therapy (such aselectrical therapy, drug therapy, and the like). A number ofenvironmental parameter types are acquired in various embodiments.Examples of these environmental types include altitude, temperature, airquality, pollen counts, humidity, and pressure. In various embodiments,the IMD parameter(s) and/or the environmental parameter(s) are trendedand/or correlated, as provided in this disclosure.

[0150] Identifying, Displaying and Assisting in CorrelatingHealth-Related Data

[0151]FIG. 23 illustrates various embodiments of the present subjectmatter related to identifying, displaying and assisting in datacorrelation. One definition of correlation is a relation existingbetween phenomena or things or between mathematical or statisticalvariables which tend to vary, be associated, or occur together in a waynot expected on the basis of chance alone. Correlating data involvesshowing a reciprocal, mutual, and/or causal relationship among the data.

[0152] Various embodiments of the present subject matter provide methodsof correlating, or assisting in the correlation of, trended data,predetermined events and other actions taken by the system (such as analert transmitted to the clinician). Various embodiments of the presentsubject matter autonomously identify correlations and display theidentified correlations. For example, various embodiments determinecorrelations without human intervention. In various embodiments, thepresent subject matter assists the clinician in correlating theinformation by displaying the data in an appropriate manner. Cause andeffect relationships that are suitable for use in treating patients canbe established by correlating data items.

[0153]FIG. 23 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of correlating trendedparameters, predetermined events, and alerts, according to variousembodiments of the present subject matter. The illustrated device 2352includes a first data input 2301 to receive trended health-relatedparameter(s), a second data input 2302 to receive predetermined event(s)associated with a patient's health, and a third data input 2303 toreceive alert(s) associated with a patient's health. According tovarious embodiments of the present subject matter, the health-relatedparameters, the predetermined events, and the alerts include any of thehealth-related parameters, the predetermined events, and the alertsprovided throughout this disclosure.

[0154] The device 2352 includes a correlation module 2304 incommunication with the first data input 2301, the second data input2302, and the third data input 2303. The correlation module 2304, whichin uses various correlation algorithms 2305 in various embodiments, isadapted to correlate at least one of one or more trended health-relatedparameters, one or more health-related predetermined events, and one ormore health-related alerts. In various embodiments, the correlationmodule 2304 is adapted to trigger an action. In various embodiments, theaction is automatically triggered based on the correlation. In variousembodiments, the correlation module automatically triggers an IMDtherapy change based on the correlation. In various embodiments, thecorrelation module automatically displays the correlation. For example,a cursor or other indicator can be used to highlight the correlation.

[0155] Those versed in the art will understand, upon reading andcomprehending this disclosure, how-to incorporate various well knowntechniques for computing correlations between two or more data sources.For example, in the case of providing correlations between two datasources, Pearson's product-moment correlations is one example of a typeof correlation that may be computed. In the case of three or more datasources, multivariate correlation techniques may be employed.

[0156] According to various embodiments of the present subject matter,the choice of which data sources to correlate is based on knowledge ofphysiological coupling between the sources. According to variousembodiments, the choice of which data sets to correlate and the timedurations(s) over which the correlations are computed is determined atthe start of monitoring, and is either the same for each patient, or istailored to individual patients based on the physicians' knowledge ofthe patient's condition. In various embodiments, the decisions of whichparameters to correlate with each other may be dynamically selectedbased on ongoing IMD or WMD monitoring of the patient's physiology.

[0157] Composite Parameter Indices

[0158] FIGS. 24-26 illustrate various embodiments of the present subjectmatter related to defining, identifying and utilizing compositeparameter indices. A composite parameter is a parameter created bycombining two or more parameter inputs. For example an exerciseconditioning composite parameter is generated by dividing a heart rateby an activity level. A lower exercise condition composite parameterindicates that a patient is in better condition. Various embodiments ofthe present subject matter provide composite parameters that function astrended parameters in various manner in which the trended parameters areused, as provided throughout this disclosure. A composite parameter iscapable of being used in any way a raw parameter is used, such asdisplaying, correlating, defining predetermined events, defining alerts,and the like.

[0159]FIG. 24 illustrates a method to generate composite parameters foruse in managing a patient's health, according to various embodiments ofthe present subject matter. The method illustrates a first parameter2406 and a second parameter 2407 being operated on to form a compositeparameter 2408. One or ordinary skill in the art will understand, uponreading and comprehending this disclosure, that the operation denoted at2409 can be any number of mathematical and/or logical operations. Forexample, the composite parameter 2408 can be formed by multiplying thefirst parameter 2406 and the second parameter 2407, or can be formed bydividing the second parameter 2407 into the first parameter 2406. Morecomplex mathematical and/or logical operations can be used to generatethe composite index.

[0160]FIG. 25 illustrates a method to generate composite parameters foruse in managing a patient's health, according to various embodiments ofthe present subject matter. The method illustrates a number ofparameters (1, 2, P) and a number of composite parameters (1, 2, C) thatare capable of being combined to form one or more composite parameters2508. Thus, the present subject matter is capable of generating acomposite parameter from any number of health-related parameters, fromany number of previously-determined composite parameters, or from anycombination of one or more parameters and one or more compositeparameters.

[0161] In various embodiments, the parameters include IMD-measuredparameters and/or IMD-interrogated parameters. IMD-interrogatedparameters include, for example, parameters related to a device statussuch as battery or lead impedance. In various embodiments, theparameters include user-inputted parameters provided by a patient,clinician or other person.

[0162] Various embodiments of the present subject matter combine two ormore health-related parameters related to a body system to generate acomposite parameter that is indicative of the health of the body system.For example, respiratory rate, tidal volume, maximum oxygen consumption(VO2) and periodic breathing parameters relate to a respiratory system.These parameters can be used to generate a single composite parameterindex that provides a health indication concerning the respiratorysystem. Another example uses an average heart rate and an activityparameter to generate a composite parameter index indicative of physicalconditioning. Other examples use cardiac output and vascular pressuresto measure vascular resistance. Another example measures respiration andheart rate to measure respiratory sinus arrhythmia.

[0163] In various embodiments, the composite index is displayed withtrended health-related parameter(s), predetermined event(s) and/oralert(s). In various embodiments, the composite parameter is used todefine a predetermined health-related event. In various embodiments, thecomposite parameter is used to define a clinician alert. In variousembodiments, the composite parameter is used to modify device therapy.

[0164]FIG. 26 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of generating compositeparameters, according to various embodiments of the present invention.The illustrated device 2652 includes a data input 2610 to receive two ormore health-related parameters and a composite generating module 2611 incommunication with the data input 2610. In operation, the compositegenerating module 2611 receives the health-related parameters andgenerates a composite parameter using the health-related parameters. Thecomposite generating module 2611 is capable of performing any number ofmathematical and/or logical operations, such as that denoted at 2409 inFIG. 24. In various embodiments, the composite generating module 2611 iscapable of combining one or more composite parameters (represented byline 2612) with one or more health-related parameters to form othercomposite parameters.

[0165] Various embodiments provide various composite parameters. Anumber of these composite parameters are identified below. Theidentified composite parameters is not intended to be an exclusive listof the available composite parameters.

[0166] In a first example, a composite parameter indicative of systemicvascular resistance (SVR) is generated using an acquired cardiac outputparameter (C.O.), a mean arterial pressure parameter (/P_(ART)), and amean right atrial pressure parameter (/P_(RA)). In various embodiments,the SVR composite parameter is provided by:${SVR} = {\frac{\overset{\_}{P_{ART}} - \overset{\_}{P_{RA}}}{C.O.}.}$

[0167] In a second example, a composite parameter indicative ofpulmonary vascular resistance (PVR) is generated using an acquiredcardiac output parameter (C.O.), a mean pulmonary artery pressureparameter (/P_(PA)), and one of a mean pulmonary capillary wedgepressure parameter (/P_(CW)) and a mean left atrial pressure parameter(/P_(LA)) In various embodiments, the PVR composite parameter isprovided by: ${{PVR} = \frac{P_{PA} - P_{CW}}{C.O.}},{or}$${PVR} = {\frac{\overset{\_}{P_{PA}} - \overset{\_}{P_{LA}}}{C.O.}.}$

[0168] In a third example, a composite parameter indicative ofrespiratory sinus arrhythmia (RSA) is generated using an acquired heartrate parameter (P_(HR)) and a parameter related to instantaneous lungvolume (P_(LV)). For example, a trans-thoracic sensor can be used in theacquisition. In various embodiments, the RSA composite parameter isprovided by:

RSA=f(P _(HR) , P _(LV))

[0169] In a fourth example, a composite parameter indicative of a degreeof dyspnea (D) is generated using an acquired respiration rate parameter(P_(RR)) and a tidal volume parameter (P_(TV)) In various embodiments,the dyspnea composite parameter is provided by:$D = {\frac{P_{RR}}{P_{TV}}.}$

[0170] Context may temporarily affect the physiological condition of amonitored patient. A patient context (or body-related concept), forexample, may include posture, activity level, mental/emotional state andthe like. Examples of patient contexts include sleeping or lying down,running, and driving. An environmental context (or external factor), forexample, may include ambient temperature, sound level and the like. Theconcept of context has previously been discussed with respect to FIG.16.

[0171] In various embodiments, the context is correlated with thephysiologic measurements. In various embodiments, measurements are takenonly for certain contexts so as to provide a repeatable baseline. Forexample, it is preferred to measure some parameters when a patient is atrest or in a known position. Thus, repeatable composite parameters canbe generated. This is useful to determine trends or deviations fromnormal values. Additionally, various embodiments determine the contextto provide an appropriate therapy for a contextual situation.

[0172] The following commonly-assigned patent applications refer to theuse of multiple parameters and are herein incorporated by reference intheir entirety: “Implantable Cardiac Rhythm Management Device ForAssessing Status of CHF Patients,” Ser. No. 09/434,009, filed Nov. 4,1999, now U.S. Pat. No. 6,275,727; “Method and Apparatus For DeterminingChanges In Heart Failure Status,” Ser. No. 10/001,223, filed Nov. 15,2001; and “Cardiac Rhythm Management Systems and Methods PredictingCongestive Heart Failure Status,” Ser. No. 10/213,268, filed Aug. 6,2002. The following commonly-assigned patent application refers tocontext and is herein incorporated by reference in its entirety:“Methods and Devices For Detection of Context When Addressing A MedicalCondition of a Patient”, Ser. No. ______, filed Oct. 11, 2002 (AttorneyDocket 13569.0054US01).

[0173] Triaging Health-Related Data

[0174] FIGS. 27-28 illustrates various embodiments of the presentsubject matter related to triaging health-related data in an advancedpatient management system. Various embodiments of the present subjectmatter provide one or more devices (such as IMD, WMD, programmer and thelike) with the ability to rank the severity of predetermined events.This ranking is used to prioritize the processing of the predeterminedevents and respond in an appropriate manner. For example, the system canbe designed such that a modest increase in heart rate holds a lowerpriority and is related to the clinician at a next patient followup;whereas a sudden increases in weight (which may be associated with acutedecompensation in a heart failure patient) may be assigned a higherpriority and immediately be communicated to the clinician throughvarious communication means.

[0175]FIG. 27 illustrates a method to triage predetermined events foruse in managing a patient's health, according to various embodiments ofthe present subject matter. At 2713, predetermined events are acquired.At 2714, the acquired predetermined events are classified, ranked,sorted or filtered according to severity. At 2715, an action istriggered based on the severity of the predetermined event. According tovarious embodiments, the action includes one or more of displaying thepredetermined event to a clinician at a patient followup visit 2716,alerting a clinician of the predetermined event at a patient followupvisit 2717, initiating an alert for the patient 2718, altering devicetherapy 2719, and initiating an alert (such as a prompt emergency alert)to the clinician using an advance patient management system 2720. Invarious embodiments, the above-identified actions are performed forpredetermined events that have been classified for increasing severitysuch that action 2716 is performed for a less severe event than action2717, which is performed for a less severe event than action 2718, whichis performed for a less severe event than action 2719, which isperformed for a less severe event than action 2710. Other actions can beperformed according to the severity of the predetermined event.

[0176] In various embodiments, the available actions to be performed areassociated with various severity levels for predetermined events. Thisinformation is stored in a computer-readable memory such that a deviceis capable of performing an action that is associated with a detectedpredetermined event.

[0177]FIG. 28 illustrates a device (such as a WMD or IMD) for monitoringa patient's health condition that is capable of classifying a number ofpredetermined events according to severity, and performing a systemaction based on the classification, according to various embodiments ofthe present subject matter. The illustrated device 2852 includes aninput module 2821 and a triage module 2822.

[0178] In various embodiments, the input module 2821 acquirespredetermined events. In various embodiments, the input module 2821includes a predetermined event determination module 2823 to determinewhether a predetermined event has occurred. In various embodiments, theinput module 2821 includes a first communication module 2824 to acquireIMD parameters for use by the predetermined event determination module2823. In various embodiments, the input module 2821 includes a secondcommunication module 2825 to acquire database parameters for use by thepredetermined event determination module.

[0179] The triage module 2822 receives the predetermined event(s) andranks or otherwise classifies, the predetermined events according toseverity. In various embodiments, the device 2852 includes a triggeringmodule 2826 in communication with the triage module 2822. The triagemodule 2822 is adapted to automatically initiate a desired action by thetriggering module 2826 based on the severity of the predetermined event.In various embodiments, the action initiated is appropriate for theseverity of the event. In various embodiments, a communication or reportis initiated by the device when a predetermined event is classified asbeing more severe. For example, the communication can be an alarm or aprominently displayed message. In various embodiments, a communicationor report is provided during a subsequent patient follow-up session whena predetermined event is classified as being less severe. In variousembodiments, the device 2852 automatically performs a desired systemaction selected from a number of available system actions. The action isselected based on the severity of the predetermined event.

[0180] Various embodiments of the present subject matter use color totriage health-related data. A first color is used to identify events ashaving a first degree of severity for which a certain action isperformed. In various embodiments of the present subject matter, two ormore colors are used to identify events as having one of two or moredegrees of severity.

[0181] Various embodiments of the present subject matter use a red colorto indicate health-related conditions and device failure conditions thatare imminently life threatening. Thus, a “red status” is a rareoccurrence, and has high selectivity and sensitivity. A red statustriggers a red alert. In various embodiments, the red alert iscommunicated to the physician and the patient. Various embodiments, forexample, contact the physician via a telephone call to the physician'scell phone or phone service, and/or via an electronic pager.

[0182] Examples of red status conditions include, but are not limitedto, the following situations. One example of a red status situationincludes a situation where the lead impedance of the ventricularshocking lead is out-of-bounds. One example of a red status situationincludes a situation where the lead impedance of the ventricular pacinglead (such as the right ventricle in cardiac rhythm therapy devices) isout-of-bounds in a patient. One example of a red status situationincludes a situation where a patient's ventricular rate is greater thanthe ventricular fibrillation rate and available shock therapy has beenexhausted. One example of a red status situation includes a situationwhere an end of life (EOL) indicator has been asserted for greater thana predetermined percentage of the anticipatedEOL-to-cessation-of-therapy interval. One example of a red statussituation includes a situation where a device failure has occurred thatwill prevent the delivery of acute life sustaining therapy.

[0183] Various embodiments of the present subject matter use a yellowcolor to indicate health-related conditions and device failures that areless severe than a red status yet are serious enough to be communicatedto the patient and/or to the physician. A yellow status triggers ayellow alert that is communicated to the patient and/or physician.Various embodiments for example, contact the physician via an e-mailmessage or other message that the physician can respond to within aperiod of time, such as a few hours or a few days. In variousembodiments, the physician is notified of a yellow alert, and thepatient is notified only after the physician has determined that medicalintervention involving the patient is required.

[0184] Examples of yellow status conditions include, but are not limitedto, the following situations. One example of a yellow status situationincludes a situation where a battery indicator has been asserted thatindicates the device has reached, or is beyond, the elective replacementtime. One example of a yellow status situation includes a situationwhere a ventricular pacing lead impedance is out-of-bounds in a patientthat is not dependent on pacing. One example of a yellow statussituation includes a situation where an atrial pacing lead impedance isout-of-bounds. One example of a yellow status situation includes asituation where a device detects the first instance of an arrhythmiatype (such as ventricular fibrillation (VF), ventricular tachycardia(VT), supraventricular tachycardia (SVT), atrial tachycardia (AT), andatrial fibrillation (AF)). One example of a yellow status situationincludes a situation where a predetermined arrhythmia type has beentreated. One example of a yellow status situation includes a situationwhere a device failure has occurred that will not prevent the deliveryof acute life sustaining therapy. One example of a yellow statussituation includes a situation where a percentage of time in AF hasincreased a predetermined amount since the last device interrogation andthe total AF time is above a predetermined amount of time.

[0185] Various embodiments of the present subject matter use a greencolor to indicate health-related conditions that are “normal.” Invarious embodiments, the green color indicates that the health-relatedcondition is a condition that does not fall within a red status or ayellow status condition. Various embodiments of the present subjectmatter allow the patient to interrogate their IMD at will betweenroutine interrogations. Many of these patient-initiated interrogationswill result in a green status, and thus will not be reviewed by aphysician.

[0186] Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement which is calculated to achieve the same purpose maybe substituted for the specific embodiments shown. This application isintended to cover any adaptations or variations of the present subjectmatter. It is to be understood that the above description is intended tobe illustrative, and not restrictive. Combinations of the aboveembodiments, and other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the presentsubject matter should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

What is claimed is:
 1. A method for use in managing a patient's healthwithin a patient management system, comprising: accessing a number ofpredetermined events related to the patient's health identified by thepatient management system; classifying each of the number ofpredetermined events according to severity using a color-code system. 2.The method of claim 1, further comprising initiating a first alert for afirst predetermined event in a first color-code class.
 3. The method ofclaim 2, further comprising automatically performing a first systemaction based on the first predetermined event in the first color-codeclass.
 4. The method of claim 1, wherein classifying each of the numberof predetermined events according to severity using a color-code systemincludes classifying a first predetermined event as a red eventindicative of a health-related condition that is imminently lifethreatening, and automatically initiating communication to quicklyinform a physician of the red event.
 5. The method of claim 4, whereinautomatically initiating communication to inform a physician of the redevent includes at least one of calling the physician, calling ananswering service of the physician, and paging the physician.
 6. Themethod of claim 4, wherein classifying each of the number ofpredetermined events according to severity using a color-code systemincludes classifying a second predetermined event as a yellow event, andautomatically initiating communication to inform a physician of theyellow event.
 7. The method of claim 6, wherein automatically initiatingcommunication to inform a physician of the yellow event includes sendinga message to inform a physician of the yellow event.
 8. The method ofclaim 7, wherein automatically initiating communication to inform aphysician of the yellow event further includes notifying the patientwhen the physician indicates that intervention by the patient isdesired.
 9. The method of claim 6, wherein classifying each of thenumber of predetermined events according to severity using a color-codesystem includes classifying a third predetermined event as a greenevent.
 10. The method of claim 9, wherein the first predetermined eventis an imminent life threatening event, the second predetermined event isa serious health-related condition that is not imminently lifethreatening, and the third predetermined event is an event that isneither an imminent life threatening event nor a serious health-relatedcondition.
 11. The method of claim 1, further comprising acquiring anumber of health-related parameters using the patient management system,and identifying an occurrence of at least one of the predeterminedevents based on the number of health-related parameters.
 12. A device,comprising: a data input module to access a number of predeterminedevents related to a patient's health; and a triage module to communicatewith the data input module and automatically color code each of thenumber of predetermined events according to severity to prioritizeprocessing of the number of predetermined events.
 13. The device ofclaim 12, wherein the triage module to automatically perform a systemaction based on the color code.
 14. The device of claim 13, wherein thetriage module to code events that are imminently life threatening with ared code, and to quickly inform a physician of the life threateningevent.
 15. The device of claim 13, wherein the triage module to codeevents that are serious health-related conditions that are notimminently life threatening with a yellow code.
 16. The device of claim13, wherein the triage module to communicate the serious health-relatedconditions to a physician, and to communicate the serious health-relatedevent to the patient if the physician indicates that intervention by thepatient is required.
 17. The device of claim 12, wherein the triagemodule to code events that are imminently life threatening with a redcode, to code events that are serious health-related events with ayellow code, and to code events that are neither imminently lifethreatening nor serious with a green code.
 18. The device of claim 17,wherein the triage module to automatically perform a system action basedon the color code.
 19. A device, comprising: means to access a number ofpredetermined events related to the patient's health within an advancedpatient management system; and means to automatically classify each ofthe number of predetermined events according to severity using acolor-coded system, the color-code system including: a red status toindicate an imminently life threatening health-related condition; ayellow status to indicate a serious health-related condition that is notimminently life threatening; and a green status to indicate ahealth-related condition that is neither an imminently life threateningcondition nor a serious heath-related condition.
 20. The device of claim19, further comprising means to automatically initiate a communicationto a physician for a red event and a yellow event.
 21. The device ofclaim 19, wherein the means to automatically initiate a communicationfor a red event and a yellow event includes: means to quickly inform aphysician of the imminently life-threatening condition for the redevent; means to inform the physician of the serious condition for theyellow event; and means to inform a patient when the physician indicatesthat the serious condition requires action by the patient.